IMST for Dementia Risk Reduction

This study is testing if Inspiratory Muscle Strength Training (IMST) can help reduce the risk of dementia in older adults. You might be able to join if you are between 60 and 80 years old and have at least one risk factor for dementia, such as high blood pressure or a family history of dementia. Participants will use a POWERbreathe® Electronic IMST device daily for 8 weeks. Researchers will measure changes in your blood pressure and thinking skills to see if the high-resistance IMST helps more than a very low-resistance (sham) version. The study is also looking at how IMST affects mood, sleep, and physical function.

Study design: This is a randomized pilot study with 30 participants, comparing two groups: one receiving high-resistance IMST and another receiving low-resistance IMST.
What's involved: You would complete assessments before, during each week of, and at the end of an 8-week intervention period, which includes daily IMST training at home.
Compensation: Not stated in the trial record.
Follow-up: Your blood pressure and executive cognitive functioning will be measured at the start and after 8 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

IMST for Dementia Risk Reduction

Recruiting

NAAges 60–80InterventionalPrevention

Florida State University

~30 participants

Updated 2026-03-27 on ClinicalTrials.gov

What's tested:Inspiratory Muscle Strength Training High-ResistanceInspiratory Muscle Strength Training Low-Resistance

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in systolic BP

Measured over Baseline, 8-weeks

+1 more outcome measured

Conditions

Systolic Blood Pressure

Blood Pressure

Depression - Major Depressive Disorder

Anxiety

Sleep Quality

Physical Function

Cognitive Function

Where it's being run

1 sites across 1 states

Florida1

Who to contact

Dr. Julia Sheffler

[email protected]

850-644-4199

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Ages 60-80

Converted telephone MoCA total score≥18

Presence of at least one dementia risk factor (e.g., MCI or subjective cognitive decline, hypertension \[SBP \>130 mmHg or on medication\], sedentary lifestyle \[\<150 min/week\], family history of dementia or self-reported APOE ε4 carrier, or mild sleep-disordered breathing; CAIDE total score \[\>5\]

Capable of independently completing or requiring minimal assistance with inspiratory muscle strength training (IMST)

Willing to adhere to the IMST protocol (approximately 5-10 minutes per day for 8 weeks)

Optional inclusion of inspiratory muscle weakness (MIP \<80 cmH₂O for men, \<70 cmH₂O for women) will also be assessed.

Exclusion

tMoCA \<18, or diagnosis of neurodegenerative illness at the discretion of principal investigator (except MCI)

Current evidence of any major psychiatric disorder including psychosis (at the discretion of principal investigator), bipolar disorder, severe major depression (PHQ-9 \> 20)

Unstable cardiovascular or pulmonary disease

Recent respiratory therapy or major medication changes

Self-reported severe untreated or unstable obstructive sleep apnea (OSA)

Recent start (within the past month) of CPAP or BiPAP, or recent use of inspiratory muscle training

Lung and eardrum injuries

Non-English speaking

Participants with a pacemaker or other medical implants containing magnets or electronics will be noted and excluded from body composition analyses.

What this trial measures

Change in systolic BPBaseline, 8-weeks
Participants will demonstrate a change in systolic blood pressure (mmHg), assessed as the average of two seated measurements obtained following two consecutive 5-minute rest periods, from baseline to post-intervention.
Change in executive cognitive functioningBaseline, 8 weeks
Participants will demonstrate a change in executive cognitive functioning, assessed using the Fluid Composite Score from the NIH Toolbox Cognition Battery. The Fluid Composite Score is derived from tasks assessing executive function, attention, working memory, episodic memory, and processing speed. Change in executive cognitive functioning will be evaluated as the difference in Fluid Composite Scores from baseline to post-intervention.

Trialytics